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Brukinsa

Active substance: zanubrutinib

zanubrutinib

Centralised EU authorisationActive

Marketing holder: BeOne Medicines Ireland Limited

Verified 2026-10-09 · EMA

Analogues in other countries
Composition
Analogues by country

Products with the same active substance registered in other countries.

CountryProducts
US 2
  • BRUKINSA
    TABLET, FILM COATED · ZANUBRUTINIB 160 mg/1
    72579-122
    BeOne Medicines USA, Inc.
  • BRUKINSA
    CAPSULE · ZANUBRUTINIB 80 mg/1
    72579-011
    BeOne Medicines USA, Inc.
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208c-cb09-75f2-8425-32585e730e1e,01a1209e-68c2-7ca6-bb9e-796a88acb09f;count=2 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
EMEA/H/C/004978
Registration status
Active
ATC code
L01EL03
Sources
  • product · EMA · EMEA/H/C/004978 · Verified 2026-10-09
  • registration_status · EMA · EMEA/H/C/004978 · Verified 2026-10-09
  • ingredients.0 · EMA · EMEA/H/C/004978 · Verified 2026-10-09